Из выступаления Hans-Henrik Parving, MD на ASN
Impact on safety
But there was another finding which was quite interesting, which you haven't seen before, and that was a safety issue. In the AVOID study, we of course recognized that we could do harm. When you do dual blockade, you should be aware of the fact that you can do harm. You can cause worsening of kidney function. You can cause low blood pressure. You can increase the potassium. We were pretty much aware of that. So, a prespecified safety issue was the following: Renal dysfunction in the AVOID study was defined as a rise in creatinine to more than 2 mg/dL or 176 micromoles/L. So that was a prespecified endpoint from a safety point of view. When we looked at the patients belonging to stage III nephropathy in the AVOID study - the 237 patients - it turned out the following: That 16% of those receiving aliskiren on top of standard treatment had this worsening. However, twice as many in the placebo group had the worsening. In another words, this safety endpoint suggests to you that kidney function was better preserved in the aliskiren group compared to the other group, and we also published those data in the New England Journal of Medicine dealing with eGFR. Однако, споры продолжаются
Из выступления оппонента, Johannes F. Mann, MD
Dual therapy - the con position
So, dual therapy with ARBs and ACEs entails substantial risks, but no evidence for renal or cardiovascular benefit, and proteinuria in that respect is of no benefit. I mean, I could treat the patient with cyclosporine, put him on NSAIDs, give him a low-salt diet, and you will certainly have his protein down, but that's probably not the way we're going along. ONTARGET has limitations, but describes the risks associated with that dual therapy. And it's a current benchmark. We have it to be beaten if it is good for the patient, but if beaten, then on patient-relevant outcomes. Proteinuria remains the surrogate marker. That may be misleading - that's the point of ONTARGET - for dual therapy, and we need large outcome trials and should not be happy with surrogate outcomes. The thing is if we, in nephrology, rely on just surrogate outcomes, we probably are not taken seriously by other subspecialties of internal medicine that consistently look at patient-relevant outcomes. If I talk to my cardiology colleagues, I don't want to see after PTCA a nice cosmetic effect, I want to see what the change in myocardial infarction is or cardiovascular death. And in that respect, proteinuria is highly cosmetic. Dual therapy is certainly not indicated to lower blood pressure or to lower cardiovascular risk, and for the renal patient, it is, at the present time, still an experimental treatment.
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